Lifestyle Scenario Demonstration on Dialysis Modality | NCT02733354

Studies
Lifestyle Scenario Demonstration on Dialysis Modality

NCT02733354

Sponsor

The Second Affiliated Hospital of Harbin Medical University

Status

Unknown status

Last Update Posted

Apr 12, 2016Estimated

Enrollment

220Estimated

Phase

Not provided

Conditions

Dialysis Mode Life Scenarios

Interventions

watch viedo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Jun 2019Estimated

Completion Date

Not provided

First Submitted Date

Apr 6, 2016

First Submission Date that Met QC Criteria

Apr 6, 2016

First Posted Date

Apr 11, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2016

Last Update Posted Date

Apr 12, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xuanyi Du, chief physician, The Second Affiliated Hospital of Harbin Medical UniversityPrincipal Investigator

Lead Sponsor

The Second Affiliated Hospital of Harbin Medical UniversityOTHER

Collaborators

Not provided

Description Module

Brief Summary

Based on real cases, daily life scenarios of peritoneal dialysis and hemodialysis patients were shooted and edited into video films, including environment of home dialysis, dietary patterns, water intake, sports mode, daily work, short time of travel and other activities, covering a certain natural day of either peritoneal or hemodialysis and some important time points in the way of life, such as nursing and treatment for common complications of the corresponding dialysis mode. The videos will also show the advantages and disadvantages of the two modes of dialysis. According to their actual living conditions, patients will decide the right dialysis modality that suite them well, thus improving dialysis compliance and psychological adaptability.

Detailed Description

By "informed decision score" questionnaire, comparison of two groups of patients on dialysis awareness of the pattern and ratio of patients choosing hemodialysis and peritoneal dialysis were performed. Dialysis mode conversion rates of the two groups were finally calculated and the correlation between awareness of dialysis modality and conversion rates of dialysis methods was analyzed.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

220Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Group		Control Group:perform routine oral education.Both groups were asked to complete kidney disease knowledge questionnaire before education.
Intervention Group		Intervention Group ：On the basis of Control Group, watching video demonstration of each type of dialysis. The videos were based on real cases, showing patients with peritoneal and hemodialysis life modes, lasting for 20 minutes respectively for each type of dialysis. Both groups were asked to complete kidney disease knowledge questionnaire before education.	Device: watch viedo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
watch viedo	Device		Intervention Group

Measure	Description	Time Frame
Conversion rates		two years

Measure	Description	Time Frame
Informed Decision Score		two years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

CKD（chronic kidney disease） stage 5 patients with replacement therapy indications, age≥ 18 years, ≤70 years
without any contraindications of peritoneal dialysis or hemodialysis

Exclusion Criteria:

Age> 70 years or <18 years old
contraindications of peritoneal dialysis or hemodialysis
Patients who cannot be followed well after dialysis.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

CKD 5 patients,prepare for dialysis, aged between 18 to 70 years old, male or female,

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
xuanyi - Du, PH D	Contact	+86 15904608957		15904608957@126.com

Overall Officials

Not provided

Locations

Not provided